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CO-BENELDOPA 200 MG/50 MG CAPSULES

Active substance(s): BENSERAZIDE HYDROCHLORIDE / LEVODOPA

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CO-BENELDOPA 50 mg/12.5 mg,
100 mg/25 mg AND 200 mg/50 mg
CAPSULES
(Levodopa/Benserazide)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
s +EEPTHISLEAFLET9OUMAYNEEDTOREADITAGAIN
s )FYOUHAVEANYFURTHERQUESTIONS ASKYOUR
DOCTORORPHARMACIST
s 4HISMEDICINEHASBEENPRESCRIBEDFORYOUONLY
$ONOTPASSITONTOOTHERS)TMAYHARMTHEM
EVENIFTHEIRSYMPTOMSARETHESAMEASYOURS
s )FANYOFTHESIDEEFFECTSGETSSERIOUS ORIFYOU
NOTICEANYSIDEEFFECTSNOTLISTEDINTHISLEAFLET
PLEASETELLYOURDOCTORORPHARMACIST3EE
SECTION
IN THIS LEAFLET:
1. What Co-Beneldopa is and what it is used for
2. What you need to know before you take
Co-Beneldopa
3. How to take Co-Beneldopa
4. Possible side effects
5. How to store Co-Beneldopa
6. Contents of the pack and other information

1

WHAT CO-BENELDOPA IS AND WHAT IT
IS USED FOR

s ,EVODOPAISANANTI 0ARKINSONSAGENTAND
BENSERAZIDEISADECARBOXYLASEINHIBITORWHICH
HELPSLEVODOPATOWORKBETTER
s #O "ENELDOPAISUSEDTOTREATTHESYMPTOMSOF
0ARKINSONSDISEASE

2

WHAT YOU NEED TO KNOW BEFORE
YOU TAKE CO-BENELDOPA

&ICTITIOUSPHARMACODEWILLBE
UPDATEDATSUPPLIERPROOFSTAGE

Do NOT take Co-Beneldopa
s )FYOUAREALLERGICHYPERSENSITIVE TOLEVODOPA
BENSERAZIDEORANYOFTHEOTHERINGREDIENTSOF
THISMEDICINE
s )FYOUHAVEHYPERTHYROIDISMANOVERACTIVE
THYROIDGLAND ANEXCESSIVELYFASTHEARTBEAT OR
PHAEOCHROMOCYTOMAATUMOUROFTHEADRENAL
GLANDTHATCAUSESHYPERTENSION
s )FYOUHAVESEVEREHORMONAL HEART LIVEROR
KIDNEYDISEASE
s )FYOUHAVEPSYCHOSISAPSYCHIATRICCONDITION
CHARACTERISEDBYPERSONALITYDERANGEMENTAND
LOSSOFCONTACTWITHREALITY
s )FYOUHAVENARROWANGLEGLAUCOMAHIGH
PRESSUREINTHEEYE
s )FYOUAREUNDERYEARSOFAGE
s )FYOUAREPREGNANT
s )FYOUAREAWOMANOFCHILD BEARINGAGENOT
USINGRELIABLECONTRACEPTIONSEESECTION
0REGNANCYANDBREAST FEEDING
s )FYOUARETAKINGRESERPINEORMONOAMINE
OXIDASE-!/ INHIBITORSEGTRANYLCYPROMINE
WHICHAREUSEDTOTREATHIGHBLOODPRESSUREAND
DEPRESSEDMOOD!LSODONOTTAKE
#O "ENELDOPAIFYOUHAVETAKENA-!/
INHIBITORWITHINTHELASTWEEKS
Warnings and precautions
4ELLYOURDOCTORBEFOREYOUTAKETHISMEDICINE
s )FYOURSYMPTOMSWERECAUSEDBYANOTHER
DRUG ORIFYOUHAVEANOTHERMOVEMENT
DISORDERCALLED(UNTINGTONgSCHOREA ASTHIS
MEDICINEMAYNOTBEAPPROPRIATE
s )FYOUHAVEEVERHADAHEARTATTACKORHEART
PROBLEMS
s )FYOUHAVEORTHOSTATICHYPOTENSIONLOWBLOOD
PRESSUREASSOCIATEDWITHCHANGESINPOSTURE
WHICHMAKESYOUFEELLIGHT HEADEDORDIZZY
s )FYOUHAVEEVERHADAPEPTICORINTESTINALULCER
s )FYOUHAVEEVERHADCONVULSIONSFITS
s )FYOUHAVEEVERHADOSTEOMALACIAABONE
DISEASESIMILARTORICKETS
s )FYOUHAVEWIDEANGLEGLAUCOMAHIGHPRESSURE
INTHEEYE
s )FYOUHAVEDIABETES9OUSHOULDCHECKYOUR
BLOODSUGARLEVELSMOREOFTEN ANDYOURDOCTOR
MAYNEEDTOADJUSTTHEDOSEOFYOURANTIDIABETIC
MEDICINE
s )FYOUAREABOUTTOUNDERGOSURGERY

&ICTITIOUSPHARMACODEWILLBE
UPDATEDATSUPPLIERPROOFSTAGE

$EPRESSIONANDSUICIDALTHOUGHTSMAYOCCUR
DURINGTREATMENTWITH#O "ENELDOPA ALTHOUGH
THEYCANALSOBECAUSEDBYYOURDISEASE)FYOU
FEELDEPRESSEDWHILSTONTREATMENT YOUSHOULD
CONTACTYOURDOCTOR
4ELLYOURDOCTORIFYOUORYOURFAMILYCARERNOTICES
YOUAREDEVELOPINGURGESORCRAVINGSTOBEHAVEIN
WAYSTHATAREUNUSUALFORYOUORYOUCANNOTRESIST
THEIMPULSE DRIVEORTEMPTATIONTOCARRYOUT
CERTAINACTIVITIESTHATCOULDHARMYOURSELFOR
OTHERS4HESEBEHAVIOURSARECALLEDIMPULSE
CONTROLDISORDERSANDCANINCLUDEADDICTIVE
GAMBLING EXCESSIVEEATINGORSPENDING AN
ABNORMALLYHIGHSEXDRIVEORANINCREASEINSEXUAL
THOUGHTSORFEELINGS9OURDOCTORMAYNEEDTO
REVIEWYOURTREATMENTS
9OUMUSTCONTINUEYOURTREATMENTASLONGASYOUR
DOCTORTELLSYOUTO3UDDENLYSTOPPINGITCOULD
CAUSEPOTENTIALLYLIFE THREATENINGSIDEEFFECTSSEE
SECTIONBELOW g)FYOUSTOPTAKING#O "ENELDOPA 
9OURDOCTORMAYWISHTOCARRYOUTCERTAINPERIODIC
TESTS SUCHASTAKINGBLOODANDURINESAMPLESAND
CHECKINGYOURHEARTRATEANDBLOODPRESSURE)N
ADDITION YOURSKINSHOULDBETESTEDFORMALIGNANT
MELANOMASONAREGULARBASIS
Other medicines and Co-Beneldopa
#HECKWITHYOURDOCTORIFYOUARETAKINGANYOFTHE
FOLLOWING
s -ONOAMINEOXIDASE-!/ INHIBITORSUSEDTO
TREATDEPRESSION THECOMBINATIONOFTHESE
MEDICINESWITH#O "ENELDOPACOULDCAUSE
EXCESSIVELYHIGHBLOODPRESSURE4HISCOULDALSO
OCCURIFYOUHAVETAKENAN-!/INHIBITORWITHIN
THELASTWEEKSSEEg$O./4TAKE
#O "ENELDOPAg ABOVE
s -EDICINESTHATCOULDSTRENGTHENORWEAKENTHE
EFFECTOF#O "ENELDOPA
s /THERMEDICINESUSEDFORTHETREATMENTOF
0ARKINSONSDISEASE SUCHASBROMOCRIPTINE
AMANTADINE TRIHEXYPHENIDYLORENTACAPONE
s &ERROUSSULPHATEUSEDTOTREATIRONDEFICIENCY

2

s -ETOCLOPRAMIDEUSEDTOTREATDIGESTIVE
DISORDERS
s -EDICINESBELONGINGTOAGROUPCALLEDOPIOIDS
SUCHASCODEINE OXYCODONE MORPHINE OR
TRAMADOLUSEDTORELIEVEPAIN
s -EDICINESFORHIGHBLOODPRESSURETHATCONTAIN
RESERPINESEEg$O./4TAKE#O "ENELDOPAg
ABOVE
s .EUROLEPTICSSUCHASHALOPERIDOL FLUPENTHIXOL
ORCHLORPROMAZINEUSEDTOTREATSOMEPSYCHIATRIC
DISORDERSINCLUDINGSEVEREANXIETYAND
SCHIZOPHRENIA NAUSEA SICKNESSANDHICCOUGHS
s -EDICINESFORHIGHBLOODPRESSUREYOURBLOOD
PRESSURECOULDBECOMETOOLOW9OURDOCTOR
MAYNEEDTOADJUSTTHEDOSEOFYOURTREATMENT
FORHIGHBLOODPRESSURE
s -EDICINESBELONGINGTOAGROUPCALLED
SYMPATHOMIMETICS SUCHASCLONIDINEOR
SALBUTAMOL SHOULDNOTBEUSEDATTHESAME
TIMEAS#O "ENELDOPATHEEFFECTOFTHESE
MEDICINESCOULDBESTRENGTHENED9OURDOCTOR
MAYNEEDTOADJUSTTHEDOSEOFYOUR
SYMPATHOMIMETICTREATMENT

02 May 2014

&ICTITIOUSPHARMACODEWILLBE
UPDATEDATSUPPLIERPROOFSTAGE

Version:

231-30-86486-ZB LEA CO-BENELDOPA A/S CAP TUK
#O "ENELDOPAMAYINTERFEREWITHTHERESULTSOF
TESTSFORLEVELSOFCERTAINCHEMICALSINTHEBLOOD
Operations
)FYOUAREGOINGTOHAVEANOPERATION TELLTHE
DOCTORTHATYOUARETAKING,EVODOPA"ENSERAZIDE
4HISISBECAUSEYOUMAYNEEDTOSTOPTAKINGIT
BEFOREYOUHAVEAGENERALANAESTHETIC
4ELLYOURDOCTORORPHARMACISTIFYOUARETAKINGOR
HAVERECENTLYTAKENORMIGHTTAKEANYOTHER
MEDICINES
Taking Co-Beneldopa with food and drink
4AKING#O "ENELDOPAWITHHIGH PROTEINMEALS
COULDREDUCEITSEFFECT
7HENPOSSIBLE YOUSHOULDTAKE#O "ENELDOPA
MINUTESTOHOURAFTERMEALS
Pregnancy and breast-feeding
9OUMUSTNOTTAKE,EVODOPA"ENSERAZIDEIFYOUARE
PREGNANT)FYOUAREOFCHILD BEARINGAGE YOUMUST
USERELIABLECONTRACEPTIONDURINGTREATMENTWITH
,EVODOPA"ENSERAZIDE
.EVERTHELESS IFYOUSTILLBECOMEPREGNANTORTHINK
YOUMAYBEPREGNANT YOUMUSTCONSULTYOUR
DOCTOR(ESHEWILLADVISEYOUHOWTOSTOP
TREATMENTWITH,EVODOPA"ENSERAZIDE
9OUSHOULDNOTBREAST FEEDDURINGTREATMENTWITH
,EVODOPA"ENSERAZIDE)FTREATMENTWITH
,EVODOPA"ENSERAZIDEISNECESSARYDURING
LACTATION YOUSHOULDSTOPBREAST FEEDINGYOUR
BABY
!SKYOURDOCTORORPHARMACISTFORADVICEBEFORE
TAKINGANYMEDICINE
Driving and using machines
,EVODOPAISASSOCIATEDWITHSOMNOLENCE
EXCESSIVEDROWSINESS AND VERYRARELY WITH
EXCESSIVEDAYTIMESLEEPINESSANDSUDDENONSET
SLEEPEPISODES4HESECANOCCURWITHOUTWARNING
SIGNS)FYOUEXPERIENCETHESESYMPTOMS YOU
MUSTINFORMYOURDOCTORANDYOUMUSTREFRAIN
FROMDRIVINGORENGAGINGINACTIVITIESWHERE
IMPAIREDALERTNESSMAYPUTYOURSELFOROTHERSAT
RISKOFSERIOUSINJURYEGOPERATINGMACHINES
UNTILSUCHRECURRENTEPISODESANDSOMNOLENCE
HAVEBEENRESOLVED

3

HOW TO TAKE CO-BENELDOPA

!LWAYSTAKE#O "ENELDOPAEXACTLYASYOURDOCTOR
HASTOLDYOU9OUSHOULDCHECKWITHYOURDOCTOROR
PHARMACISTIFYOUARENOTSURE
MGMGSTRENGTH
4REATMENTWITH#O "ENELDOPAISUSUALLYSTARTED
WITHLOWDOSES EGONECAPSULETWOTOFOURTIMES
ADAY
MGMGSTRENGTH
4REATMENTWITH#O "ENELDOPAISUSUALLYSTARTED
WITHLOWDOSES#O "ENELDOPAMGMG
#APSULESARENOTAPPROPRIATEFORTHISANDTHE
MGMGSTRENGTHISAVAILABLEFORTHIS
PURPOSE
MGMGSTRENGTH
4REATMENTWITH#O "ENELDOPAISUSUALLYSTARTED
WITHLOWDOSES#O "ENELDOPAMGMG
#APSULESARENOTAPPROPRIATEFORTHISANDTHE
MGMGSTRENGTHISAVAILABLEFORTHISPURPOSE
MGMGSTRENGTH!FTERTHREETOSEVENDAYS
YOURDOCTORMAY IFNECESSARY BEGINTOINCREASE
YOURDOSEBYONEORTWOCAPSULESEVERYTHIRDTO
SEVENTHDAY UNTILYOUACHIEVESUITABLECONTROLOF
YOURSYMPTOMS
MGMGSTRENGTH!FTERTHREETOSEVENDAYS
YOURDOCTORMAY IFNECESSARY BEGINTOINCREASE
YOURDOSEBYONECAPSULEEVERYTHIRDTOSEVENTH
DAY UNTILYOUACHIEVESUITABLECONTROLOFYOUR
SYMPTOMS
MGMGSTRENGTH!FTERTHREETOSEVENDAYS
YOURDOCTORMAY IFNECESSARY BEGINTOINCREASE
YOURDOSEEVERYTHIRDTOSEVENTHDAY UNTILYOU
ACHIEVESUITABLECONTROLOFYOURSYMPTOMS
#O "ENELDOPAMGMG#APSULESARENOT
APPROPRIATEFORTHISANDOTHERSTRENGTHSARE
AVAILABLETOTHISEND
4HEMAXIMUMDOSEISGENERALLYNOMORETHAN
MGMGSIXTEENCAPSULESADAY
MGMGEIGHTCAPSULESADAY
MGMGFOURCAPSULESADAY
4HEDAILYDOSESHOULDBESPREADOUTOVERTHEDAY
INTOSEVERALSMALLERDOSES4HESIZEOFINDIVIDUAL
DOSESANDTHEWAYTHEYARESPREADTHROUGHOUTTHE
DAYMUSTBEADJUSTEDTOSUITTHENEEDSOFEACH
INDIVIDUALPATIENT
)TMAYTAKESEVERALWEEKSFORTHEFULLEFFECTOFYOUR
MEDICINETOBECOMEAPPARENT
)FYOUHAVEPREVIOUSLYTAKENLEVODOPAONITSOWN
ORWITHANOTHERDECARBOXYLASEINHIBITOR YOU
SHOULDSTOPTAKINGITTWELVEHOURSBEFOREYOUSTART
TAKING#O "ENELDOPA
7HENPOSSIBLE YOUSHOULDTAKE#O "ENELDOPA
MINUTESTOHOURAFTERMEALS9OUMUSTSWALLOW
THECAPSULESWHOLE WITHOUTCHEWINGTHEM WITHA
DRINK

&ICTITIOUSPHARMACODEWILLBE
UPDATEDATSUPPLIERPROOFSTAGE

TEVA UK Ref:

TEVA UK Ref:

Version:

231-30-86486-ZB LEA CO-BENELDOPA A/S CAP TUK
2

If you take more Co-Beneldopa than you should
)FYOUORSOMEONEELSE SWALLOWALOTOFTHE
CAPSULESALLTOGETHER ORIFYOUTHINKACHILDHAS
SWALLOWEDANYOFTHECAPSULES CONTACTYOUR
NEARESTHOSPITALCASUALTYDEPARTMENTORYOUR
DOCTORIMMEDIATELY0LEASETAKETHISLEAFLET ANY
REMAININGCAPSULESANDTHECONTAINERWITHYOUTO
THEHOSPITALORDOCTORSOTHATTHEYKNOWWHICH
CAPSULESWERECONSUMED

s )RRESISTIBLEURGETOMOVEYOURLEGSTOSTOP
UNCOMFORTABLEORODDSENSATIONS
s "LEEDINGINDIGESTIVETRACT
s $ISCOLOUREDSALIVA TONGUE TOOTHORMOUTH
s &LUSHINGANDSWEATING


4HESESIDEEFFECTSTYPICALLYOCCURATTHE
BEGINNINGOFTREATMENTANDCANUSUALLYBE
CONTROLLEDBYTAKING#O "ENELDOPAWITHFOODOR
DRINKANDBYINCREASINGTHEDOSEMORESLOWLY

/VERDOSEMAYCAUSEAWORSENINGOFYOUR
SYMPTOMS ASWELLASCONFUSION HALLUCINATIONS
ANDSLEEPDISTURBANCES.AUSEAANDVOMITING
FEELINGANDBEINGSICK ANDABNORMALHEART
RHYTHMSMAYRARELYOCCUR

Reporting of side effects
)FYOUGETANYSIDEEFFECTS TALKTOYOURDOCTOR
PHARMACISTORNURSE4HISINCLUDESANYPOSSIBLE
SIDEEFFECTSNOTLISTEDINTHISLEAFLET9OUCANALSO
REPORTSIDEEFFECTSDIRECTLYVIATHE9ELLOW#ARD
3CHEMEATWWWMHRAGOVUKYELLOWCARD
"YREPORTINGSIDEEFFECTSYOUCANHELPPROVIDE
MOREINFORMATIONONTHESAFETYOFTHISMEDICINE

If you forget to take Co-Beneldopa
$ONOTTAKEADOUBLEDOSETOMAKEUPFORA
FORGOTTENDOSE4AKEYOURNEXTDOSEASUSUAL
HOWEVER YOUMAYEXPERIENCESOMERETURNOF
0ARKINSONSDISABILITYINTHEMEANTIME

5

HOW TO STORE CO-BENELDOPA

Keep out of the sight and reach of children.
If you stop taking Co-Beneldopa
9OURDOCTORWILLADVISEYOUWHENYOUSHOULDSTOP
TAKING#O "ENELDOPA5SUALLY ITISTAKENFORALONG
TIMESINCEITREPLACESASUBSTANCE DOPAMINE
WHICHISNOTPRODUCEDINSUFFICIENTAMOUNTSBY
PATIENTSWITH0ARKINSONSDISEASE
9OUMUSTTELLYOURDOCTORIFYOUWANTTOSTOP
TAKING#O "ENELDOPA!LTHOUGHITISRARE SUDDEN
DISCONTINUATIONOFTREATMENTCANCAUSEPOTENTIALLY
LIFE THREATENINGSIDEEFFECTS INCLUDINGACONDITION
CALLEDNEUROLEPTICMALIGNANT LIKESYNDROME WHICH
INVOLVESGREATLYELEVATEDBODYTEMPERATURE
MUSCLESTIFFNESSANDPSYCHOLOGICALCHANGES AND
AKINETICCRISISINABILITYTOMOVE 4OAVOIDTHESE
YOURDOCTORWILLADVISEYOUHOWTOENDYOUR
TREATMENT
)FYOUHAVEANYFURTHERQUESTIONSONTHEUSEOFTHIS
PRODUCT ASKYOURDOCTORORPHARMACIST

4

POSSIBLE SIDE EFFECTS

,IKEALLMEDICINES THISMEDICINECANCAUSESIDE
EFFECTS ALTHOUGHNOTEVERYBODYGETSTHEM
You may experience the following side effects:
s INABILITYTORESISTTHEIMPULSETOPERFORMAN
ACTIONTHATCOULDBEHARMFUL WHICHMAY
INCLUDE
s STRONGIMPULSETOGAMBLEEXCESSIVELY
DESPITESERIOUSPERSONALORFAMILY
CONSEQUENCES
s ALTEREDORINCREASEDSEXUALINTERESTAND
BEHAVIOUROFSIGNIFICANTCONCERNTOYOUORTO
OTHERS FOREXAMPLE ANINCREASEDSEXUAL
DRIVE
s UNCONTROLLABLEEXCESSIVESHOPPINGOR
SPENDING
s BINGEEATINGEATINGLARGEAMOUNTSOFFOOD
INASHORTTIMEPERIOD ORCOMPULSIVEEATING
EATINGMOREFOODTHANNORMALANDMORE
THANISNEEDEDTOSATISFYYOURHUNGER 
Tell your doctor if you experience any of these
behaviours; they will discuss ways of managing or
reducing the symptoms.
4HEFOLLOWINGSIDEEFFECTSHAVEBEENREPORTEDAT
THEAPPROXIMATEFREQUENCIESSHOWN
Very common (may affect more than 1 in 10
people)
s 3LEEPDISTURBANCES ESPECIALLYINTHEELDERLY
s $EPRESSEDMOOD
ESPECIALLYINTHEELDERLY
s ,OSSOFAPPETITE
s &LUCTUATIONSINRESPONSESUCHAS@FREEZING
MOVEMENTSUDDENLYBECOMINGDIFFICULT
@END OF DOSEARETURNOFSYMPTOMSBEFORETHE
NEXTDOSEOFMEDICINEISDUE AND@ON OFF
PHENOMENASUDDENCHANGESFROMPERIODSOF
GOODSYMPTOMCONTROLTOPERIODSWHERE
SYMPTOMSARELESSCONTROLLED

s $ISTORTEDORIMPAIREDVOLUNTARYMOVEMENT
DYSKINESIA
s )NVOLUNTARYMOVEMENTS
)NTHELATERSTAGESOFTREATMENT ANDINMANY
CASESAFTERTHEMEDICINEHASBEENTAKENFOR
MANYYEARS UNCONTROLLABLE UNUSUAL
MOVEMENTSOFTHEARMS LEGS FACEANDTONGUE
CANOCCUR4HESEMAYDISAPPEARIFTHEDAILY
DOSEISCHANGEDORIFTHESPREADOFDOSES
THROUGHOUTTHEDAYCANBEIMPROVED
s .AUSEA

s 6OMITING

s $IARRHOEA

s )NCREASEDLEVELSOFTHESUBSTANCEALKALINE
PHOSPHATASEINBLOOD
s )NCREASEDLEVELSOFTHESUBSTANCESURICACIDOR
UREANITROGENINBLOOD

$ONOTUSETHISMEDICINEAFTERTHEEXPIRYDATE
WHICHISSTATEDONTHEBOTTLEANDOUTERPACKAGING
4HEEXPIRYDATEREFERSTOTHELASTDAYOFTHEMONTH
4HISMEDICINALPRODUCTDOESNOTREQUIREANY
SPECIALSTORAGECONDITIONS
$ONOTTHROWAWAYMEDICINESVIAWASTEWATEROR
HOUSEHOLDWASTE!SKYOURPHARMACISTHOWTO
DISPOSEOFMEDICINESNOLONGERREQUIRED4HESE
MEASURESWILLHELPTOPROTECTTHEENVIRONMENT

6

CONTENTS OF THE PACK AND OTHER
INFORMATION

What Co-Beneldopa contains
s 4HEACTIVESUBSTANCESARELEVODOPAAND
BENSERAZIDE
s /NECAPSULECONTAINSMGOF
LEVODOPAANDMGOFBENSERAZIDEAS
HYDROCHLORIDE 
s 4HEOTHERINGREDIENTSAREASFOLLOWS
Capsule contents:MANNITOL CELLULOSE
MICROCRYSTALLINE POVIDONE+  TALC
MAGNESIUMSTEARATE
Capsule shell: GELATIN TITANIUMDIOXIDE%
BLACKIRONOXIDE% MGREDIRON
OXIDE% ERYTHROSIN% INDIGOCARMINE
% 
Printing ink:SHELLAC PROPYLENEGLYCOL
POTASSIUMHYDROXIDE BLACKIRONOXIDE
What Co-Beneldopa looks like and contents of the
pack
s #O "ENELDOPAMGMG#APSULESARE
HARDGELATINCAPSULESWITHANOPAQUEGREYCAP
IMPRINTED@AXIALLYINBLACKINK ANDAN
OPAQUEBLUEBODYIMPRINTED@",AXIALLYINBLACK
INK ANDFILLEDWITHOFF WHITETOBROWNISHWHITE
GRANULES!VAILABLEINWHITEOPAQUEBOTTLESWITH
AWHITECAPWITHDESICCANTCONTAINING 
 ANDCAPSULES
s #O "ENELDOPAMGMG#APSULESAREHARD
GELATINCAPSULESWITHANOPAQUEPINKCAP
IMPRINTED@AXIALLYINBLACKINK ANDAN
OPAQUEBLUEBODYIMPRINTED@",AXIALLYINBLACK
INK ANDFILLEDWITHOFF WHITETOBROWNISHWHITE
GRANULES!VAILABLEINWHITEOPAQUEBOTTLESWITH
WHITECAPWITHDESICCANTCONTAINING  
 ANDCAPSULESINCONTAINER
s #O "ENELDOPAMGMG#APSULESAREHARD
GELATINCAPSULESWITHANOPAQUEMAROONCAP
IMPRINTED@AXIALLYINBLACKINK ANDAN
OPAQUEBLUEBODYIMPRINTED@",AXIALLYINBLACK
INK ANDFILLEDWITHOFF WHITETOBROWNISHWHITE
GRANULES!VAILABLEINWHITEOPAQUEBOTTLESWITH
WHITECAPWITHDESICCANTCONTAINING AND
CAPSULESINCONTAINER
.OTALLPACKSIZESMAYBEMARKETED
Marketing Authorisation Holder and Manufacturer
4%6!5+,IMITED %ASTBOURNE ".!'
This leaflet was last revised in 03/2014.
0,
0,
0,

Common (may affect up to 1 in 10 people):
s (ALLUCINATIONS ESPECIALLYINTHEELDERLY
s !NXIETY ESPECIALLYINTHEELDERLY
s !BNORMALHEARTRHYTHM
s #HANGESINBLOODPRESSURE WHICHCANBE
IMPROVEDBYREDUCINGTHEDOSE
s 4ASTEALTERATIONS

Uncommon (may affect up to 1 in 100 people):
s 4ASTELOSS

Rare (may affect up to 1 in 1,000 people):
s $ECREASEDWHITEBLOODCELLCOUNTS
Not known (frequency cannot be estimated from
the available data):
s $ECREASEDREDBLOODCELLORPLATELETCOUNTS
s $ISORIENTATIONINTIME ESPECIALLYINTHEELDERLY
s !GITATION ESPECIALLYINTHEELDERLY
s $ELUSIONS ESPECIALLYINTHEELDERLY
s -ILDELATION
s $ROWSINESS
s !GGRESSION
s g5NMASKINGgOFPSYCHOSISAPSYCHIATRIC
CONDITIONCHARACTERISEDBYPERSONALITY
DERANGEMENTANDLOSSOFCONTACTWITHREALITY
s $OPAMINEDYSREGULATIONSYNDROME
s #ONFUSION
s %XCESSIVEDAYTIMESLEEPINESS
s 3LEEPEPISODES
s $ISCOLOUREDURINE USUALLYRED TINGED

s )LLNESSACCOMPANYINGKIDNEYFAILUREURAEMIA
s )NCREASEDLEVELSOFTHESUBSTANCES
TRANSAMINASESINBLOOD
s !LLERGICSKINREACTIONSSUCHASITCHINGANDRASH
4%6A UK ,IMITED

 :"

02 May 2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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